IRBMED - UMMS

ORIO Guidance: Miscllaneous Information

Investigators sometimes receive information that has a direct impact on a research study. This information is reportable to the IRBMED. Frequently this information falls within the Adverse Event Reporting context, or it is reported to IRBMED in conjunction with a protocol, investigatorship, or informed consent amendment. When those contexts don't apply, information should be reported as an ORIO.

To determine whether or not information received by the investigator needs to be reported to the IRBMED, consider the following criteria:

Does the information constitute an unanticipated problem involving risks to subjects or others?
Are safety issues raised?
Is there an impact on the risk/benefit ratio of the study?
Could the information affect subjects' willingness to participate?
Does the information concern sponsor, investigator, or research staff compliance with federal regulations and/or IRBMED policies and procedures?
Has a research subject become a prisoner?

If the answer to any of these questions is YES, then report to the IRBMED.

Other types of miscellaneous information that must be passed on to the IRBMED are publications (e.g. an article in JAMA pertinent to the research); General Summary or Annual Reports that an investigator makes to or receives from an oversight body like a DSMB or the FDA that may include summaries of adverse events; summaries of IND safety reports; labeling changes on a drug or device; other new information pertinent to the effectiveness of an intervention or interaction; or general progress of a study (see 21 CFR 312.33 and 21 CFR 812.150).

The examples below illustrate the some (but not all) of information that should be passed on to the IRBMED as an ORIO application.

Audits and Inspections

IRBMED requires audit and inspection findings be submitted for review (see Reports below). This includes both internal and external audits. We recommend that investigators contact IRBMED prior to a government agency (e.g. FDA) or sponsor inspection or site visit so that IRBMED staff has on hand any documentation that may be requested.

Examples:

FDA conducts a for-cause inspection of a clinical trial in response to a complaint from a research participant and the inspector requests copies of the IRBMED correspondence with the investigator related to an earlier IRB received complaint from the same subject
FDA conducts an inspection as part of the approval process for a New Drug Application and requests copies of all "Notices of Outcome" some of which are missing from the investigator's file.
A study sponsor conducts a routine, yearly audit.

Reports and Letters from Oversight Agencies

Reports from internal oversight bodies (such as the Cancer Center Clinical Trials Office or the Office of the Vice President for Research) or outside agencies (such as the FDA, NCI, NIH, or sponsor) should be submitted to the IRBMED for review according to the ORIO or AE Timetables. This includes reports/letters that are about the study in general or about the UM site in particular. Written responses from the investigator should also be submitted to the IRBMED.

Examples:

NCI releases a summary report about the use of the study agent in UM studies and studies involving other cancers not being investigated at UM.
FDA conducts a New Drug Application or other for-cause site visit and provides the investigator with a Form 483 with findings.
Sponsor determines that Adverse Events were not reported to the IRBMED at the correct time.

Subject incarceration

Regulations and guidance from the Department of Health and Human Services require that IRBs conduct special review not only on studies that intend to recruit prisoners, but also to re-review studies according to the Prisoner Research Regulations when a research subject becomes a prisoner, or when a study not originally reviewed for prisoner recruitment seeks to enroll a prisoner. When the principal investigator and the subject wish to enroll or continue a prisoner's participation in the study the following steps must be taken:

Page one of the co-chairs of the IRBMED through UMHS paging (See About IRBMED: Emergencies).
Send an urgent email to the IRBMED office immediately (the same day as the study is notified of the incarceration or possibility of prisoner enrollment).
Do not perform any study intervention or interaction (except those necessary to eliminate apparent immediate hazards to the subject) until contacted by an IRBMED co-chair or otherwise directed by the UMHS Legal Office. If an intervention/interaction was required to protect the subject, all of these steps must still be followed.
Prepare and submit a Previously Approved Project Application.
- Provide as much information as possible about the subject's incarceration including:
  1. Name of facility where subject is incarcerated
  2. Address of facility
  3. Phone number and contact person within the facility
  4. Reasons why new subject should be enrolled or existing subject's participation in the study should continue
  5. For studies involving administration of drugs, devices, surgery or other type of intervention that would normally be conducted in a medical facility, explain where and under what circumstances the invention will now take place
- Email the completed application to the IRBMED office and hand-deliver (or use over-night delivery service) the signed paper copy of the application to the IRBMED office

Examples of situations requiring notice to IRBMED prior to any further study intervention or interaction::

A research subject is arrested and held in jail awaiting trial. For the subject's health and safety, the PI believes administration of the study drug should continue during incarceration.
During a long term (20 year) study, the investigator discovers a subject is serving a prison term. The subject wants to continue participation (being interviewed by phone once a year) in the study during her prison stay.
A Phase III Chemotherapy Trial offers the best or only option for cancer treatment of a prisoner in a Michigan State Prison.
A participant in a depression study is committed to hospital while on a study anti-depressant that should not be abruptly discontinued.